Phase
Condition
Pancreatic Cancer
Pancreatitis
Pancreatic Disorders
Treatment
CT041 autologous CAR T-cell injection
Clinical Study ID
Ages 18-79 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Voluntary participation in the clinical trial; fully understand, be informed aboutthis study and have signed the ICF; willing to follow and able to complete all studyprocedures;
Aged 18 to 79 years;
Histologically confirmed pancreatic ductal adenocarcinoma;
Macroscopic complete tumor removal (R0 or R1 resection);
Postoperative pathological stage (pTNM): T1-3, N0-2, M0;
Immunohistochemistry (IHC) staining of subject's tumor tissue sample isCLDN18.2-positive;
Subjects had recovered from surgery and had received 3 months of standard adjuvanttherapy;
Abnormal CA19-9 level;
With sufficient venous access for leukapheresis collection;
ECOG performance status score 0-1;
Adequate organ function;
Men and women of childbearing potential must be willing to use effective methods ofcontraception to prevent pregnancy;
Exclusion
Exclusion Criteria:
Prior neoadjuvant therapy for pancreatic cancer;
Subjects with borderline resectable pancreatic cancer;
Present or past history of metastatic or locally recurrent pancreatic cancer;
Evidence of malignant ascites;
Subjects had diseases that may interfere with CA19-9 level, including but notlimited to cholangitis, pancreatitis, obstructive jaundice, etc.
Toxicities caused by previous treatment have not recovered to CTCAE ≤ grade 2,except alopecia and other tolerable events as judged by the investigator orlaboratory abnormalities allowed in this study;
Pregnant or lactating women;
Positive serology for HIV, Treponema pallidum or HCV;
Any active infections, including but not limited to active tuberculosis, HBV, EBV,CMV, COVID-19 infections;
Clinically significant thyroid dysfunction;
Previous allergy to immunotherapy and related drugs, allergy to CT041 ingredientsand other serious allergic history;
Subjects who may be at high risk for potential digestive tract bleeding orperforation;
Known active autoimmune disease, including but not limited to, psoriasis orrheumatoid arthritis, or other conditions requiring long-term immunosuppressivetherapy;
Subjects who have a history of organ transplantation or are awaiting organtransplantation;
Subjects who require anticoagulant therapy;
Subjects who are receiving or are expected to require long-term antiplatelet therapyduring the study;
Subjects who have experienced major surgery or have significant trauma within 4weeks before apheresis, or who are expected to undergo major surgery during thestudy period;
Previously received any gene-modified cell therapies (including CAR T, TCR T);
Subjects who have other serious diseases that may restrict them from participatingin the study assessed by investigators;
Subjects with oxygen saturation ≤ 95%;
Subjects who have signs of central nervous system diseases or clinically significantneurological examination abnormalities;
Subjects who have other uncured malignant tumors in the past 3 years or at the sametime, except those with very low degree of malignancy such as cervical cancer insitu and basal cell carcinoma of skin;
Vaccination with live attenuated vaccines within 4 weeks prior to apheresis orplanned during the study;
Subjects who are unable to or unwilling to comply with the requirements of the studyprotocol as assessed by investigators.
Study Design
Study Description
Connect with a study center
Beijing Cancer Hospital
Beijing, Beijing
ChinaActive - Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
ChinaActive - Recruiting
Union Hospital, Tongji Medical College, Hua zhong University of Science and Technology
Wuhan, Hubei
ChinaActive - Recruiting
Hunan Provincial People's Hospital
Changsha, Hunan
ChinaActive - Recruiting
Fudan University Shanghai Cancer Hospital
Shanghai, Shanghai 201321
ChinaActive - Recruiting
Ruijin Hospital, affiliated to Shanghai Jiaotong University, school of medicine
Shanghai, Shanghai 200025
ChinaActive - Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xian, Shanxi
ChinaActive - Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
ChinaActive - Recruiting

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